21 CFR 801.20

§ 801.20 Label to bear a unique device identifier.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 801.20, § 801.20 Label to bear a unique device identifier, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88661
Permanent ID: ys:prov:88661@1
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Full text

(a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter. (2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter. (b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.